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Developing a Virtual Reality Training Tool for Exposure Therapy: Simulated Exposure Trainer (SET)

Developing a Virtual Reality Training Tool for Exposure Therapy: Simulated Exposure Trainer (SET)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06706245
Acronym
SET-VR
Enrollment
42
Registered
2024-11-26
Start date
2023-12-01
Completion date
2024-07-03
Last updated
2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-immersion (Head Mounted Display), Low-immersion (Mobile Device)

Keywords

Virtual reality, exposure to exposure, therapist negative beliefs, exposure therapy, evidence-based practices, Simulated Exposure Trainer, virtual training program

Brief summary

The goal of this study is to develop a targeted virtual training program (Simulated Exposure Trainer; SET) for exposure therapy. Two platforms with differing levels of immersion (low - mobile device; high - head mounted display) will be evaluated based on their usability and engagement of an empirically-derived training target (i.e., therapist negative beliefs). Target engagement will be evaluated by applying an experimental therapeutics framework during a brief training trial.

Detailed description

Despite the existence of numerous, well-established evidence-based practices (EBPs) for mental disorders, it has been difficult to disseminate these practices in community settings. Exposure therapy for anxiety disorders represents one of the most glaring examples of this research-to-practice gap. Just as patients are anxious about approaching their fears, therapists are often reluctant to use exposure therapy due to their own anxious beliefs that it may be dangerous and/or intolerable for patients, even after receiving specialized exposure training. Emerging training research suggests the inclusion of targeted behavioral strategies (i.e., role play, self-exposure) can reduce anxious beliefs above and beyond standard didactic training sessions. By leveraging the same behavior change principles that reduce patient anxiety (i.e., exposure), behavioral strategies can be tailored to target therapists' anxious beliefs about the treatment (i.e., conduct training as exposure to exposure). Unfortunately, current experiential training tasks have failed to closely replicate commonly feared clinical contexts, and as a result lack the necessary potency to potentially overcome therapist-level barriers for uptake and quality treatment delivery following training. Virtual reality (VR) has demonstrated utility as a potent and cost-effective approach for delivering exposure. We plan to investigate the application of VR as a tailored training tool (i.e., virtual exposure to exposure for therapists) capable of enhancing the quantity and quality of experiential learning that is lacking in current exposure training initiatives. This study will test the implementation of a VR training program on both a low-immersion (i.e., mobile device) and high-immersion (i.e., head mounted display) platform to assess which platform provides the ideal balance of immersion, usability, target engagement, and scalability. The study involves a clinical training trial to establish target engagement. Usability and target engagement information from this pilot trial will support a Phase II project aimed at building out and broadly disseminating the VR-enhanced training approach.

Interventions

BEHAVIORALSET-VR (computer)

Low-immersive version of the SET-VR program

BEHAVIORALSET-VR (headset)

High-immersive version of the SET-VR program

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Bradley Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Bachelor's level of education (or higher) * Able to come to study site in-person for experiential training * Has the ability to provide some sort of clinical care to patients

Exclusion criteria

* Found study procedures to be unacceptable during the consent process

Design outcomes

Primary

MeasureTime frameDescription
Therapist Negative Beliefs About Exposure Scale (TBES)Before workshop starts (Baseline); immediately after 4-hour didactic portion of training (Post-didactic), immediately after remaining workshop activities (End of workshop), one month after workshop (Follow-up)The Therapist Negative Beliefs about Exposure Scale (TBES) assesses the extent to which therapists agree with 21 negative beliefs about exposure therapy (e.g., most clients have difficulty tolerating the distress exposure therapy evokes). Items are rated on a 5-point scale from 0 (disagree strongly) to 4 ( agree strongly). Possible scores range from 0 to 84, with a higher score indicating more negative beliefs about exposure.

Secondary

MeasureTime frameDescription
Exposure Self-EfficacyBefore workshop starts (Baseline); immediately after 4-hour didactic portion of training (Post-didactic), immediately after remaining workshop activities (End of workshop), one month after workshop (Follow-up)This is a 27-item measure of therapists' confidence in delivering exposure therapy. The first 8 items are about the therapist's ability to help patients learn skills related to exposure (e.g., I feel confident in my ability to help my clients identify how avoidance is maintaining their fear), and the remaining 19 items assess the therapist's confidence with implementing exposure various aspects of exposure (e.g., I feel confident in my ability to conduct imaginal exposure). Items are rated scale ranging from 1 (not confident) to 5 (very confident). This measure has demonstrated high internal consistency and predictive validity in determining the frequency of self-reported clinical use of exposure therapy.
Exposure KnowledgeBefore workshop starts (Baseline); immediately after 4-hour didactic portion of training (Post-didactic), immediately after remaining workshop activities (End of workshop), one month after workshop (Follow-up)We condensed the original 49-item Exposure Knowledge measure into 12 multiple-choice items that best fit the didactic content of the training (e.g., Why is it important to block avoidance during exposure tasks?). The total score is the percentage out of 100 of correct answers.

Countries

United States

Participant flow

Participants by arm

ArmCount
Low-immersion (Mobile Device)
SET-VR (computer): Low-immersive version of the SET-VR program
21
High-immersion (Head-mounted Display)
SET-VR (headset): High-immersive version of the SET-VR program
20
Total41

Baseline characteristics

CharacteristicTotalLow-immersion (Mobile Device)High-immersion (Head-mounted Display)
Age, Continuous40 years42 years37 years
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants20 Participants19 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
34 Participants17 Participants17 Participants
Sex: Female, Male
Male
5 Participants3 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 20
other
Total, other adverse events
0 / 210 / 20
serious
Total, serious adverse events
0 / 210 / 20

Outcome results

Primary

Therapist Negative Beliefs About Exposure Scale (TBES)

The Therapist Negative Beliefs about Exposure Scale (TBES) assesses the extent to which therapists agree with 21 negative beliefs about exposure therapy (e.g., most clients have difficulty tolerating the distress exposure therapy evokes). Items are rated on a 5-point scale from 0 (disagree strongly) to 4 ( agree strongly). Possible scores range from 0 to 84, with a higher score indicating more negative beliefs about exposure.

Time frame: Before workshop starts (Baseline); immediately after 4-hour didactic portion of training (Post-didactic), immediately after remaining workshop activities (End of workshop), one month after workshop (Follow-up)

ArmMeasureGroupValue (MEAN)Dispersion
Low-immersion (Mobile Device)Therapist Negative Beliefs About Exposure Scale (TBES)Baseline28.76 score on a scaleStandard Deviation 8.96
Low-immersion (Mobile Device)Therapist Negative Beliefs About Exposure Scale (TBES)Post-Didactic21.19 score on a scaleStandard Deviation 10.94
Low-immersion (Mobile Device)Therapist Negative Beliefs About Exposure Scale (TBES)Post-Experiential16.33 score on a scaleStandard Deviation 9.06
Low-immersion (Mobile Device)Therapist Negative Beliefs About Exposure Scale (TBES)Follow Up14.71 score on a scaleStandard Deviation 10.23
High-immersion (Head-mounted Display)Therapist Negative Beliefs About Exposure Scale (TBES)Follow Up15.95 score on a scaleStandard Deviation 10.61
High-immersion (Head-mounted Display)Therapist Negative Beliefs About Exposure Scale (TBES)Baseline30.9 score on a scaleStandard Deviation 10.49
High-immersion (Head-mounted Display)Therapist Negative Beliefs About Exposure Scale (TBES)Post-Experiential16.65 score on a scaleStandard Deviation 10.5
High-immersion (Head-mounted Display)Therapist Negative Beliefs About Exposure Scale (TBES)Post-Didactic21.2 score on a scaleStandard Deviation 10.03
Secondary

Exposure Knowledge

We condensed the original 49-item Exposure Knowledge measure into 12 multiple-choice items that best fit the didactic content of the training (e.g., Why is it important to block avoidance during exposure tasks?). The total score is the percentage out of 100 of correct answers.

Time frame: Before workshop starts (Baseline); immediately after 4-hour didactic portion of training (Post-didactic), immediately after remaining workshop activities (End of workshop), one month after workshop (Follow-up)

ArmMeasureGroupValue (MEAN)Dispersion
Low-immersion (Mobile Device)Exposure KnowledgeBaseline42.46 percentage of correct answersStandard Deviation 15.34
Low-immersion (Mobile Device)Exposure KnowledgePost-Didactic50.79 percentage of correct answersStandard Deviation 18.8
Low-immersion (Mobile Device)Exposure KnowledgePost-Experiential51.98 percentage of correct answersStandard Deviation 16.44
Low-immersion (Mobile Device)Exposure KnowledgeFollow Up53.57 percentage of correct answersStandard Deviation 18.92
High-immersion (Head-mounted Display)Exposure KnowledgeFollow Up45.83 percentage of correct answersStandard Deviation 16.11
High-immersion (Head-mounted Display)Exposure KnowledgeBaseline34.17 percentage of correct answersStandard Deviation 15.5
High-immersion (Head-mounted Display)Exposure KnowledgePost-Experiential45.42 percentage of correct answersStandard Deviation 13.91
High-immersion (Head-mounted Display)Exposure KnowledgePost-Didactic45.83 percentage of correct answersStandard Deviation 16.11
Secondary

Exposure Self-Efficacy

This is a 27-item measure of therapists' confidence in delivering exposure therapy. The first 8 items are about the therapist's ability to help patients learn skills related to exposure (e.g., I feel confident in my ability to help my clients identify how avoidance is maintaining their fear), and the remaining 19 items assess the therapist's confidence with implementing exposure various aspects of exposure (e.g., I feel confident in my ability to conduct imaginal exposure). Items are rated scale ranging from 1 (not confident) to 5 (very confident). This measure has demonstrated high internal consistency and predictive validity in determining the frequency of self-reported clinical use of exposure therapy.

Time frame: Before workshop starts (Baseline); immediately after 4-hour didactic portion of training (Post-didactic), immediately after remaining workshop activities (End of workshop), one month after workshop (Follow-up)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026